EP3570772B1 - Systeme und verfahren zur mechanischen verschiebung einer speiseröhre - Google Patents

Systeme und verfahren zur mechanischen verschiebung einer speiseröhre Download PDF

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Publication number
EP3570772B1
EP3570772B1 EP18741612.8A EP18741612A EP3570772B1 EP 3570772 B1 EP3570772 B1 EP 3570772B1 EP 18741612 A EP18741612 A EP 18741612A EP 3570772 B1 EP3570772 B1 EP 3570772B1
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EP
European Patent Office
Prior art keywords
segment
esophageal
outer tube
vacuum
distal
Prior art date
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Active
Application number
EP18741612.8A
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English (en)
French (fr)
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EP3570772A4 (de
EP3570772A1 (de
Inventor
Veeral M. OZA
Adam Hensel
Emile DAOUD
Nishaki MEHTA
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Ohio State Innovation Foundation
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Ohio State Innovation Foundation
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Publication date
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Priority to EP23218023.2A priority Critical patent/EP4316389A3/de
Publication of EP3570772A1 publication Critical patent/EP3570772A1/de
Publication of EP3570772A4 publication Critical patent/EP3570772A4/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/015—Control of fluid supply or evacuation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/273—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the upper alimentary canal, e.g. oesophagoscopes, gastroscopes
    • A61B1/2733—Oesophagoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
    • A61B5/4222—Evaluating particular parts, e.g. particular organs
    • A61B5/4233—Evaluating particular parts, e.g. particular organs oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A61B2018/00488—Esophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0077—Devices for viewing the surface of the body, e.g. camera, magnifying lens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/687—Oesophagus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/02—Stethoscopes
    • A61B7/023—Stethoscopes for introduction into the body, e.g. into the oesophagus

Definitions

  • This disclosure relates to medical devices and methods for vacuum suction adherence of the esophagus coupled with mechanical displacement of an esophagus of a patient.
  • AF atrial fibrillation
  • the cost of treating a patient with AF ranges from $2,000 U.S. to over $10,000 U.S. each year.
  • the most effective and expanding method of treating AF is with a procedure called catheter ablation.
  • Catheter ablation is designed to deliver energy (for example, radiofrequency and cryoenergy) through a catheter that is placed in the left atrium of the heart. The ablation results in destruction of the heart cells.
  • the areas of the heart that are targeted for ablation are the areas that cause AF.
  • the subsequent healing results in a hole/communication between the heart (a sterile organ) and the esophagus (not sterile organ).
  • This communication may result in an infection of the heart and stroke.
  • An atrial-esophageal fistula occurs in about 0.6% of patients and the outcome is nearly always fatal or associated with significant morbidity.
  • the precursor to an atrial-esophageal fistula is ulcers in the esophagus, which are also due to injury of the esophagus and occurs in about 30% of patients.
  • electrophysiologists, physicians who perform the ablation procedure are quite concerned about preventing damage to the esophagus and to avoid atrial-esophageal fistula.
  • devices, systems, and methods for vacuum suction adherence and mechanical displacement of an esophagus are provided.
  • assemblies for use with a vacuum system and an esophageal positioning device are disclosed.
  • mechanical esophageal displacement systems, and methods of use are disclosed.
  • the esophagus is a flexible muscular organ and is often moved during medical procedures. If mere mechanical force is applied to move the esophagus, tenting of the esophagus may result rather than actual movement and displacement of a region of the organ. More specifically, the mechanical force will displace the leading edge of the esophageal wall, but the trailing edge of the esophageal wall will move only a small distance, if any. The resulting tenting of the esophagus fails to provide protective benefit from the mechanical displacement.
  • the systems disclose herein utilize suction vacuum to apply a uniform force to the esophagus to pull the esophageal wall in and adhere the esophageal walls in a circumferential manner.
  • the entire circumferential segment of the esophagus is displaced and there is no lagging or trailing edge of the esophagus.
  • the esophagus follows the directional changes of the esophageal positioning device via the assembly. This directional change can be easily visualized by the physician on the x-ray equipment via the use of radiopaque markers. The visualization provides immediate feedback to the physician. By moving the esophagus outside the ablation field, the AF procedure can proceed relatively safely without risk of damage to the esophagus, and the operator can ablate the targeted areas with confidence without concern for esophageal damage.
  • FIGS. 1-25 show an example of a mechanical esophageal displacement system 1 in accordance with the present disclosure for mechanically displacing an esophagus during a medical procedure via vacuum suction adherence of a segment of the esophagus.
  • the example mechanical esophageal displacement system 1 includes an assembly 5 and an esophageal positioning device 13, in which the assembly 5 is operatively coupleable to a vacuum system (not shown).
  • the assembly 5 is a disposable component of the mechanical esophageal displacement system 1, in which the assembly 5 includes one or more disposable pieces that can be removed and or replaced after a medical procedure.
  • the esophageal positioning device 13 includes a handle 105, a first segment 110, a second segment 115, an articulation pivot pin 16, and an articulation driving mechanism 120.
  • the first segment 110 and the second segment 115 may be linear structures for example.
  • FIGS. 2-5 , 13 , 25 show an example of an assembly 5 that is disposable in accordance with the present disclosure.
  • the example assembly 5 includes an introducer 2 that is sized to receive the esophageal positioning device 13.
  • the esophageal positioning device 13 may be a reusable component of the system 1, which is to be inserted into the lumen of the introducer 2 after the introducer is advanced down the esophagus of a patient 37.
  • the introducer 2 and the esophageal positioning device 13 are manufactured as a single device, and the single piece assembly 5 may be disposable or designed to be sterilized for repeated uses.
  • the patient 37 may be a human or other animal.
  • the introducer 2 includes a soft outer tube 125.
  • the soft outer tube 125 is cylindrical.
  • the soft outer tube 125 is sized such that it may pass through a mouth or nasal passage into an esophagus.
  • the soft outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137, and a body 140.
  • the body 140 includes a contiguous inner surface 145.
  • the body 140 of the outer tube includes a perforated outer surface 150 and along the length of the outer tube, and one or more internal vacuum passages 21 (see FIGS.
  • the perforated outer surface 150 includes a plurality of vacuum holes 3 spaced circumferentially around, and extending radially from, the soft outer tube 125, as seen in FIGS. 1-3 . Because the plurality of vacuum holes 3 are spaced circumferentially around the soft outer tube 125, the plurality of vacuum holes 3 are located on multiple sides of the tube 125 and can suction the esophagus from multiple directions.
  • the one or more internal vacuum passages 21 are in fluid communication with the plurality of vacuum holes 3 to apply a vacuum to an esophageal wall via the vacuum system.
  • the outer tube 125 can be made of, for example, a soft polymer like polyvinyl chloride (PVC) or silicone.
  • PVC polyvinyl chloride
  • the outer tube 125 is flexible enough to not add unnecessary stiffness to the system 1 to which the esophageal positioning device 13 would need to overcome, but not too flexible such that the outer tube 125 bunches up while inserting the introducer 2 into the esophagus.
  • the outer tube 125 includes a lubricious material coating (e.g., hydro-glide) to facilitate introduction into the esophagus and to minimize esophageal trauma.
  • the outer tube 125 can be made of a single material, in some embodiments, a multi-durometer outer tube 125 is made of more than one material to achieve a desired stiffness at different portions along the outer tube 125.
  • the distal end 130 is made of a stiffer material, for example, a combination of silicone and polyurethane or other materials, while a portion between the distal end 130 and the proximal end 135 that includes a plurality of radial vacuum holes 3 is made of a more pliable material. The stiffer distal end 130 better facilitates introduction of the soft outer tube 125 into the esophagus.
  • the more pliable material of the portion containing the plurality of radial vacuum holes 3 allow this portion of the soft outer tube 125 to collapse, creating a smaller diameter of the soft outer tube 125 and enhancing the collapse of the esophagus. Consequently, this moves the esophagus further away from the heart and provides better circumferential adherence of the esophagus to the soft outer tube 125.
  • the assembly 5 could include a telescoping mechanism on at least a portion of the device to facilitate entry of the device into the esophagus. Once in the desired location within the esophagus, the telescoping portion could extend to deploy the entire device.
  • the perforated outer surface 150 of the introducer 2 can include a plurality of radial vacuum holes 3 which may be positioned at various locations about the outer surface 150.
  • the plurality or radial vacuum holes 3 are positioned along the outer surface 150 starting at about between three to five inches from a tube tip 4 and span a length of about two inches from the starting location.
  • the plurality of holes 3 are designed to be in fluid communication with the one or more internal vacuum passages 21 such that a vacuum system can create a vacuum between an esophageal wall and the outer tube 125 when the vacuum is coupled to the assembly 5 and turned on.
  • Fluid communication may be direct or indirect.
  • the one or more internal vacuum passages 21 extend towards but not to the distal end 130.
  • the one or more internal vacuum passages 21 extend up to but not past the location of the most distal of the radial vacuum holes 3.
  • the one or more internal vacuum passages 21 extend through the entire length of the body 140.
  • the one or more internal vacuum passage 21 comprises one or more cylindrical rings that each or together define a cavity that are axially aligned with the lumen 137 (not shown).
  • the body 140 does not include one or more internal vacuum passages 21, but rather the plurality of radial vacuum holes 3 are in fluid communication with the lumen 137 and the vacuum is applied to the lumen 137 to create a vacuum between the esophageal wall and the outer tube 125.
  • Any suitable vacuum system may be used that is able to provide sufficient suction to adhere a portion of the outer tube 125 to a portion of the esophageal wall.
  • One suitable example vacuum system is a vacuum pump that provides a suction of 300 millimeters of mercury.
  • the mechanical esophageal displacement system 1 includes a feedback mechanism, such as a manometer, to confirm that a vacuum seal has been formed along the esophagus by measuring the change in pressure in the system.
  • the introducer 2 can include a tube tip 4 located at the distal end 130 of the outer tube 125.
  • the tube tip 4 comprises a hard polymer tip having a soft, circular contour, in which the tip is bonded to the distal end 130 of the outer tube 125, in which the tube tip 4 is a closed structure.
  • the tube tip 4 is shaped to not harm the esophagus as the tube tip 4 is designed to be in direct contact with the esophageal passageway.
  • the tube tip 4 may comprise a half dome shape for example.
  • the tube tip 4 is a closed structure and not luminal.
  • the assembly 5 can further includes a vacuum port 155 comprising a vacuum port body 6 and a vacuum port cap 7.
  • the vacuum port cap 7 is a hard polymer cap that is bonded to the vacuum port body 6.
  • the vacuum port cap 7 can further include a snap feature geometry and a quick release hinge mechanism (not shown) in order to couple and de-couple the handle of the esophageal positioning device 13 to the proximal end 135 of the outer tube 125.
  • the vacuum port body 6 includes a vacuum line hook up 170 that is in fluid communication with the one or more internal vacuum passages 21.
  • the vacuum port body 6 may be bonded to both the introducer 2 and the vacuum port cap 7 to create an air tight seal.
  • the body 6 further includes a vacuum port valve and a lever (not shown), in which the lever may control the vacuum system.
  • the introducer 2 further includes a plurality of radiopaque markers (not shown) located proximal to a location 180 where the pivot pin 16 would reside within the introducer 2.
  • the plurality of radiopaque markers span distally along or within the outer tube 125 of the introducer 2 from the location 180 of about where the pivot pin 16 would reside to the location of the tube tip 4.
  • the plurality of radiopaque markers span a distance of about four to six centimeters from the tube tip 4.
  • the radiopaque markers are throughout the outer tube 125.
  • the esophageal positioning device 13 includes a handle 105, a first segment 110, a second segment 115, an articulation pivot pin 16, and an articulation driving mechanism 120.
  • the second segment 115 is sized to displace the esophageal wall by about 4 centimeters upon articulation. In some embodiments the second segment 115 is between four to six centimeters long.
  • the second segment 115 may comprise a distal band laminate assembly 12, a distal band guard 8, and a distal pivot retainer 14, in which the distal band assembly 12 houses a plurality of distal bands 185. As shown in FIGS.
  • the distal band guard 8 retains the distal band assembly 12 at a distal end 190 by a pin 9 that passes through the plurality of distal bands 185.
  • the distal band assembly 12 may be made from various suitable materials, including for example, 420 stainless steel or a hard polymer.
  • the plurality of distal bands 185 may be made from spring steel for example.
  • the distal pivot retainer 14 may be made of 420 stainless steel or 17-4 stainless steel for example.
  • the plurality of distal bands 185 may be assembled to the distal pivot retainer 14 by welding, using pins or bonding.
  • the distal bands 185 may be rigidly attached to the distal pivot retainer 14 as the bands 185 are free to flex at the distal end 190.
  • all but one of the distal bands 185 has a slot 195 at a distal end as to not interfere with the pin when the bands are being flexed.
  • One distal band 10, either the top or outer band includes a hole 200 rather than a slot 195, in which the hole 200 restricts the band 10 from sliding when the plurality of distal bands 185 are being flexed.
  • the hole 200 further assists with locating the plurality of distal bands 185 of the distal band assembly 12.
  • the distal guard 8 has a rounded tip 205 that is free of sharp edges to prevent damage to the outer soft tube 125 during insertion.
  • the first segment 110 includes a proximal pivot retainer 15, an articulation drive cable 18, and a proximal band laminate assembly 19.
  • the proximal band assembly 19 includes a plurality of proximal bands 210.
  • the proximal pivot retainer 15 houses the proximal laminate band assembly 19.
  • the proximal bands 210 can be rigidly attached to the proximal pivot retainer 15 as the proximal bands 210 are free to flex at a proximal end 215 in the handle 105.
  • the proximal pivot retainer 15 limits the distal pivot retainer 14 from articulating more than a selected angle to each side, for example 45 degrees, to prevent risk of damage to the esophagus due to excessive translation.
  • the proximal band laminate assembly 19 may provide stiffness in a direction 220 that is normal to the direction of the esophageal pathway ( FIG. 15 ) while maintaining flexibility in the direction 225 of the esophageal pathway. Flexibility may be maintained through the use of thin bands that are stacked on one and other ( FIG 14 ) to form a body that is think in the direction of the normal force provided by the esophagus ( FIG 15 ).
  • the proximal band laminate assembly 19 may be made from various suitable materials, including for example, 420 stainless steel or a hard polymer.
  • the plurality of proximal bands 210 may be made from spring steel for example.
  • the articulation pivot pin 16 may be made from 420 stainless steel or 17-4 stainless steel, for example.
  • the articulation pivot pin 16 connects both the distal pivot retainer 14 and proximal pivot retainer 15 and allows them to pivot.
  • the articulation pivot pin 16 may be pressure fit into the proximal pivot retainer 15 and held in a loose fit by the distal pivot retainer 14.
  • the mechanical esophageal displacement system 1 further includes an articulation drive cable 18.
  • This cable 18 can transmit an input force by a user from the handle 105 to the articulation pivot pin 16 to articulate the second segment 110 left or right 45 degrees from the neutral position wherein the distal band assembly 12 and the proximal band assembly 19 are parallel to each other.
  • the mechanical esophageal displacement system 1 includes a feedback mechanism that measures and displays the distance the device is articulated from its neutral position.
  • the cable 18 is approximately 0.024" in diameter and is made of a braided stainless steel or polymers such as UHMWPE, Vectran or Orion.
  • the mechanical esophageal displacement system 1 further includes an articulation cable crimp 17.
  • the cable crimp 17 can be a small ball, compressed and friction fit onto a stainless steel braided cable 18. This crimp 17 provides a feature on the cable 18 that can interface with the distal pivot retainer 14 when pulled to the left or right in order to articulate the system 1. The ball may be compressed and friction fit onto the articulation cable 18 to provide an interfacing surface.
  • the articulation drive cable 18 is coupled to the distal pivot retainer 14 by welding in addition to or as an alternative to a cable crimp 17. Other types of mechanical of chemical fasters may be used to operatively couple the articulation drive cable 18 to the distal pivot retainer 18, such as being integrally formed, chemically bonded, or mechanically or magnetically joined.
  • the mechanical esophageal displacement system 1 further includes a plurality of proximal band cable guides 20 that guide the articulation cable 18 from the handle 105 to the articulation pivot pin 16, wherein the plurality of proximal band cable guides 20 are evenly spaced along the plurality of proximal bands 210.
  • the proximal band cable guides 20 may be welded or bonded to one or more of the proximal bands 210 so as to keep the proximal bands 210 aligned while still allowing the bands 210 to slip and translate independently when bent.
  • the proximal band cable guides 20 assist with guiding the articulation drive cables 18 down the length of the esophageal positioning device 13.
  • the proximal band cable guides 20 provide additional stiffness and structure to the proximal band laminate assembly 19 while still allowing the laminate band assembly 19 to bend.
  • the handle 105 of the esophageal positioning device 13 may include a variety of components.
  • the handle 105 includes a two piece outer housing comprising an articulation handle case half 22 and a locking handle case half 23.
  • the articulation handle case half 22 may be made of a polymer or metal, and may be approximately 1.9" in diameter and approximately 5" long, for example.
  • the articulation handle case half 22 may house the plurality of proximal bands 185, the articulation drive mechanism 120 as well as an articulation control knob 25.
  • the locking handle case half 23 may made of a polymer or metal, and may be approximately 1.9" in diameter and approximately 5" long, for example.
  • the locking handle case half 23 may house the proximal bands 185, the articulation drive mechanism 120, and a locking control knob 24.
  • the locking control knob 24 may be twisted to add friction to the system 1 as well as to completely lock the system 1 at a selected articulation angle. Twisting the locking control knob 25 in the opposite direction frees the articulation drive mechanism 120 to allow the articulation driving mechanism 120 to move freely.
  • the knob 24 may be approximately one inch in overall diameter, for example.
  • the articulation control knob 25 may be rotated in a first or second direction.
  • rotating the control knob in a clockwise direction may articulate the tube tip 4 of the assembly 5 to the right while rotating the control knob 25 counter clockwise may articulate the tube tip 4 of the assembly 5.
  • the diameter of the articulation control knob 25 may be approximately two inches for example.
  • the articulating control knob 25 may articulate the second segment 115 to the right when rotated in a first direction and articulate the second segment 115 to the left when rotated in a second direction.
  • the handle 105 of the esophageal positioning device 13 may include one or more snap hooks 26 that are located on the articulation handle case half 22 and or on the locking handle case half 23.
  • the snap hooks 26 can be used to interface and couple the handle 105 to the vacuum port cap 7 of the assembly 5.
  • the handle 105 of the esophageal positioning device 13 may include a top handle band retainer 27, a bottom handle band retainer 28, a pulley gear 29, a cable pulley 30, an input gear 31, a proximal band handle retainer pin 32, a locking cone clutch 33, an articulation input shaft 34, an articulation input shaft bushing 35, and an articulation pulley shaft bushing 36, for example.
  • the top and bottom handle band retainers 27, 28 house the proximal end 215 of the plurality of proximal bands 185 via pin, hole, and slot features of the proximal bands 185 to allow the bands 185 to translate while bending.
  • the top and bottom retainers 27, 28 may be made of a polymer or aluminum, for example.
  • the top and bottom retainers 27, 28 may be held in place together by ribs 230 found on the articulation handle case half 22 and on the locking handle case half 23.
  • pulley gear 29 comprises a large gear that is attached to the cable pulley 30 via two pins. In some embodiments, the pulley gear 29 is concentric with the locking control knob 24 and a pulley shaft 235. In some embodiments, the pulley gear 29 is approximately two to three times larger in diameter than the diameter of the input gear 31.
  • the articulation cables 18 are attached to the cable pulley 30 with the right side cable 18 being attached to a top pulley hole 250.
  • the articulation cable 18 may be routed around the pins of the cable pulley 30.
  • the input gear 31 is a small gear that is attached to an articulation control knob shaft 255 and to the pulley gear 29.
  • the input gear 31 is used to lower the amount of input torque required by the user of the system 1 when articulating the esophageal positioning device 13.
  • the input torque may be lowered by a factor of two to three, for example, based on a given ratio of input gear 31 to pulley gear 29.
  • the operator does not need to, or is restricted from, exerting more than 80 ounces per inch of torque to control the knobs 24, 25.
  • a failsafe mechanism may be employed such that the articulation control knob 25 becomes locked upon an operator exerting a preset torque (e.g., more than 80 ounces per inch) to the articulation control knob 25.
  • the lockout of the knob 25 may thus assist in avoiding injury to the operator.
  • the proximal band handle retainer pin 32 interfaces with the proximal band laminate assembly 19, and the top and bottom handle band retainers 27, 28 to hold the proximal bands 185 in place.
  • the proximal band handle retainer pin 32 align parts of the top and bottom handle band retainer 27, 28, when assembled together.
  • the retain pin 32 aligns with the slots in the proximal bands 185 except for one, which allows the bands 185 to slip past one another when bending.
  • the locking cone clutch 33 may be attached to the locking control knob 24 via a screw 260 and interfering ribs 265.
  • the locking cone clutch 33 may include threads on an outer diameter that interface with threads of the locking handle case half 23.
  • the articulation input shaft 34 has a flat face that is, for example, D-shaped. The flattened face allows for interface with the input gear 31 via a set screw.
  • the input shaft 34 may be approximately .25 inches in diameter for example.
  • the articulation input shaft bushing 35 allows the articulating input shaft 34 to freely spin.
  • the articulation pulley shaft bushing 36 allows the articulating pulley shaft 34 to freely spin. The articulating input shaft bushing 35 and the articulating pulley shaft bushing 36 further assist in maintaining appropriate alignment of the handle 105 components.
  • the esophageal positioning device 13 includes a clutch and or a force gauge system to limit the torque that may be exerted by a user.
  • a sensor e.g., a thermistor or temperature sensor
  • the esophageal positioning device 13 includes multiple sensors (e.g., thermistors and/or temperature sensors) along the device to allow the measuring of temperature simultaneously at varied anatomic positions of the esophagus.
  • the thermistor, temperature, or other sensor is operatively connected to a computer, in which the computer displays a virtual image of the introducer 2 and or the esophageal positioning device 13 via a mapping screen.
  • the thermistor, temperature, or other sensor is used to display the device in a real-time imaging display (e.g., MRI, ultrasound (intracardiac, transesophageal, or transthoracic) or CT imaging), so to achieve three-dimensional imaging of the anatomy and the device.
  • the introducer 2 or the esophageal positioning device 13 includes a port to receive a gastrograffin injection or other material used to outline and visualize the esophagus on an x-ray.
  • a ratcheting articulation control is provided such that one click of the ratcheting articulation control knob in a counter clockwise direction could causes 15 degrees of articulation to the left or 1.5 cm of translation to the left depending on which is desirable for the operator.
  • audible clicks are provided as feedback to the operator as to the mount of tension being deliver to a knob.
  • a safety release mechanism is incorporated into the esophageal positioning device 13 so to prevent excessive force upon the esophagus.
  • the esophageal positioning device 13 includes other imaging devices for use with visualizing techniques.
  • imaging devices can include, for example, a fiber optic light source with a camera, ultrasound imaging (e.g., Doppler), etc. These imaging devices can be used to visualize the esophagus before, during, and after application of ablation energy and at other times during the procedure.
  • the ultrasound imaging can be used, for example, to visualize and measure through the esophagus to view intracardiac objects such as catheters, transseptal techniques/equipment, evaluation of intracardiac thrombi, evaluation of intracardiac defects such as an atrial septal defect, visualize / measure pulmonary vein devices, visualize/measure mapping devices (e.g., multi-electrode baskets), visualize/measure the left atrial appendage and left atrial appendage closure devices, visualize/measure devices placed inside the pericardium, and other cardiac related products.
  • intracardiac objects such as catheters, transseptal techniques/equipment, evaluation of intracardiac thrombi, evaluation of intracardiac defects such as an atrial septal defect, visualize / measure pulmonary vein devices, visualize/measure mapping devices (e.g., multi-electrode baskets), visualize/measure the left atrial appendage and left atrial appendage closure devices, visualize/measure devices placed inside the pericardium, and other cardiac related products.
  • the band laminates of the distal or proximal band assemblies 12, 19 have differing widths.
  • FIG. 25 shows an example of a proximal band assembly 19 having proximal bands 210 having differing widths.
  • the widths of the distal or proximal bands 185, 210 can be shaped to maximize stiffness depending on profile shape of the outer tube 125 of the introducer 2. For example, if the profile shape the outer tube 125 of the introducer 2 is circular, the distal or proximal bands 185, 210 may be cut such that the profile of the bands 185, 210 take the shape of a circle.
  • the use of differing widths can provide a more space efficient interaction between the bands 185, 210 and the outer tube of the introducer 2 or cable band guide 20.
  • cutting the bands of the proximal assembly 19 (or distal assembly 12) in different widths may increases the stiffness of the system 1 as the amount of material that is in contact with the inner surface of the outer tube or cable band guide 20 is increased.
  • all parts of the assembly 5 are made of non-ferrous materials to allow for use with advanced mapping systems or in an MRI procedure room.
  • An example method includes inserting an assembly 5 into an esophagus of a patient 37 via a mouth or nasal passage ( FIG. 13 ).
  • the assembly 5 includes an introducer 2 having a soft cyclical outer tube 125, a vacuum port 155, and a tube tip 4.
  • the soft outer tube 125 being sized to pass through a mouth or nasal passage of a patient into an esophagus, in which the soft outer tube 125 includes a distal end 130, a proximal end 135, a lumen 137 (see FIGS. 4 and 25 ), and a body 140.
  • the body 140 of the outer tube 125 includes a perforated outer surface 150, and one or more internal vacuum passages 21 that extend a distance from the proximal end 135 towards the distal end 130 within the body 140 of the outer tube 125.
  • the perforated outer surface 150 includes a plurality of vacuum holes 3 spaced circumferentially around, and extending radially from, the soft outer tube 125, as seen in FIGS. 1-3 . Because the plurality of vacuum holes 3 are spaced circumferentially around the soft outer tube 125, the plurality of vacuum holes 3 are located on multiple sides of the tube 125 and can suction the esophagus from multiple directions.
  • the one or more internal vacuum passages 21 are in fluid communication with the plurality of vacuum holes 3 to apply a vacuum to an esophageal wall via the vacuum system.
  • the tube tip 4 being located at the distal end 130 of the outer tube 125.
  • the vacuum port 155 includes a vacuum port body 6, a vacuum line hook up 170, and a vacuum port cap 7.
  • the body includes a contiguous inner surface 145.
  • the example method further includes advancing an esophageal positioning device 13 through the outer tube of the introducer 2, in which the esophageal positioning device 13 includes a handle 105, a first segment 110, a second segment 115, an articulation pivot pin 16, and an articulation driving mechanism 120.
  • the first segment 120 being coupled to the handle 105.
  • the second segment 115 being pivotally connected to the first segment 110 via the articulation pivot pin 16.
  • the articulation driving mechanism 120 being configured to pivot the second segment 115 about the first segment 110 upon articulation.
  • the example method further includes snapping the handle 105 of the esophageal positioning device 13 to the vacuum port cap 7 of the introducer 2, engaging the vacuum system to adhere a portion of the outer tube 125 to an esophageal wall, and articulating the articulation driving mechanism 120 to pivot the second segment 115 about the first segment 110 to a selected angle, for example an angle of about 45 degrees.
  • FIG. 26 shows another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system includes a flexible coil 410 wrapped around a portion of the esophageal displacement device. Similar to the embodiment found in FIG. 1 above, the example mechanical esophageal displacement system of FIG. 26 can displace the esophagus about 4 centimeters, for example, 3.992 centimeters.
  • FIG. 27 is a perspective, zoomed in view of the example mechanical esophageal displacement system of FIG. 26 .
  • the view highlights an articulation pin that is operatively coupled to a coil to articulate the segments of the esophageal positioning device about the pin.
  • FIG. 28 is a top, zoomed in view of the example mechanical esophageal displacement system of FIG. 26 , in which the view highlights example dimensions.
  • FIG. 29 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure. Similar to the embodiment found in FIG. 1 above, the example mechanical esophageal displacement system of FIG. 29 includes pulleys and cables to articulate the respective segments of the esophageal positioning device.
  • FIG. 30 is a perspective view of an example assembly of the mechanical esophageal displacement system of FIG. 29 .
  • the view shows an outer tube 125 having a long tail 412 with radiopaque markers 414.
  • FIG. 31 is perceptive, cross sectional view of a portion of the mechanical esophageal displacement system of FIG. 29 .
  • the view highlights vacuum passages 21 and holes of the assembly.
  • FIG. 32 is a front view of a portion of the mechanical esophageal displacement system of FIG. 29 .
  • the view highlights the connection between the segments of the esophageal positioning device.
  • the view includes a clevis 515, pin 516, cable 518, crimp 517, welds 518, and top 514 and bottom 516 pulley halves.
  • FIG. 33 is a perceptive view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the view shows an esophageal positioning device having a fishing rod 610, eyelets 612, a cinch wire 614, and cables 618, in which the cables house an anchor 616.
  • FIG. 34 is a perceptive, cross sectional view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 34 includes an esophageal displacement device that rotates to compress a spring 710 operatively coupled to the assembly.
  • FIG. 35 is a perspective view of another example assembly in accordance with the present disclosure.
  • the assembly includes a tube 825 having a collapsible portion 810, in which the collapsible portion 810 can be actuated by guide wires and/or vacuum pressure.
  • FIG. 36 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 36 includes an esophageal displacement device that provides articulation via shafts 910, 912, a right-hand threaded rod 914, and a left-hand threaded rod 916, wherein the right-hand threaded rod 914 and a left-hand threaded rod 916 are coupled together axially.
  • FIG. 37 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 37 includes a gear drive 1010 that provides articulation via a worm gear 1012.
  • FIG. 38 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 38 includes a gear drive 1110 that provides articulation via a leaf spring 1112.
  • FIG. 39 is a perspective view of another example assembly in accordance with the present disclosure.
  • the assembly includes an outer tube 1210, similar to outer tube 125, made of a material that deforms to a particular shape when wet.
  • FIG. 40 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 40 includes a top 1310 and bottom section 1312 that are matched together via a set of axial ridges 1314, 1316, respectively, in which the axial ridges 1314, 1316 prevent rotation.
  • the top 1310 and bottom sections 1312 are connected loosely via a wire 1318.
  • the bottom section 1312 is locked into place when the wire 1318 is pulled up.
  • FIG. 41 is a perspective view of another example mechanical esophageal displacement system in accordance with the present disclosure.
  • the mechanical esophageal displacement system of FIG. 40 includes an esophageal displacement device having two pieces 1410, 1412 having angled faces 1414, 1416, respectively, in which the angle between of the two pieces 1410, 1412, changes from being aligned to being perpendicular upon rotation.
  • FIG. 42 is a perspective view of another example assembly in accordance with the present disclosure.
  • the assembly of FIG. 42 includes a straw like tube 1510 that has a flexible portion 1512 only on one side 1514, thus the vacuum when applied causes the one side 1514 of the assembly to deflect.
  • FIG. 43 is a perspective view of another example assembly in accordance with the present disclosure.
  • the assembly of FIG. 43 includes a gel liquid portion 1610 that causes the assembly to deflect in a given direction.

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Claims (14)

  1. Mechanisches Ösophagusverschiebesystem (1), das eine Anordnung (5) umfasst, die funktionell mit einem Vakuumsystem und einer Ösophaguspositioniervorrichtung (13) gekoppelt ist, wobei die Ösophaguspositioniervorrichtung (13) einen Griff (105) umfasst, der wahlweise mit der Anordnung (5) gekoppelt werden kann, ein erstes Segment (110), das mit dem Griff gekoppelt ist, ein zweites Segment (115), das schwenkbar mit dem ersten Segment (110) über einen Gelenkdrehzapfen (16) verbunden ist, und einen Gelenkantriebsmechanismus (120), der das zweite Segment (115) um das erste Segment (110) zwischen einer ersten Position und einer zweiten Position bei der Gelenkbewegung schwenkt, wobei das erste Segment (110) eine zentrale Achse aufweist und das zweite Segment (115) ein distales Ende aufweist, wobei das distale Ende des zweiten Segments (115) entlang der zentralen Achse in der ersten Position positioniert ist und das distale Ende des zweiten Segments (115) von der zentralen Achse in der zweiten Position versetzt ist, wobei die Anordnung umfasst:
    ein Einführungselement (2), umfassend:
    ein weiches Außenrohr (125), das so bemessen ist, dass es durch einen Mund oder einen nasalen Durchgang in einen Ösophagus hindurchgeht, wobei das weiche Außenrohr ein distales Ende (130), ein proximales Ende (135), ein Lumen (137) und einen Körper (140) umfasst, wobei der Körper mehrere radiale Vakuumlöcher (3) ausbildet, die in Umfangsrichtung rund um das weiche Außenrohr beabstandet sind, und einen oder mehrere innere Vakuumdurchlässe (21), die sich über eine Strecke vom proximalen Ende zum distalen Ende innerhalb des Körpers des Außenrohrs erstrecken, wobei der eine oder die mehreren inneren Vakuumdurchlässe in Fluidverbindung mit den mehreren Vakuumlöchern stehen, um über das Vakuumsystem ein Vakuum an eine Ösophaguswand anzulegen; und
    eine Rohrspitze, die sich am distalen Ende des äußeren Rohrs befindet,
    wobei das distale Ende des zweiten Segments (115) in der ersten Position und in der zweiten Position den gleichen Abstand von dem Gelenkdrehzapfen (16) beibehält.
  2. Mechanisches Ösophagusverschiebesystem (1) nach Anspruch 1, wobei die Schlauchspitze eine harte Polymerspitze mit einer weichen, kreisrunden Kontur umfasst, wobei die Spitze mit dem distalen Ende (130) des Außenrohrs (125) verbunden ist.
  3. Mechanisches Ösophagusverschiebesystem (1) nach Anspruch 1, wobei das Einführungselement ferner einen Vakuumdurchlass (155) beinhaltet, der einen Vakuumdurchlasskörper (6) und eine Vakuumdurchlasskappe (7) umfasst, wobei der Vakuumdurchlasskörper einen Vakuumleitungsanschluss (170) umfasst, der in Fluidverbindung mit dem einen oder den mehreren inneren Vakuumdurchlässen (21) steht, wobei der Vakuumdurchlasskörper sowohl mit dem Einführungselement als auch mit der Vakuumdurchlasskappe verbunden ist, um eine luftdichte Abdichtung zu schaffen; vorzugsweise wobei die Kappe des Vakuumanschlusses eine Kappe aus Hartpolymer beinhaltet, die mit dem Körper des Vakuumanschlusses verbunden ist und eine Schnappfunktion und einen Schnelllösescharniermechanismus beinhaltet, um wahlweise einen Griff der Ösophaguspositioniervorrichtung (13) mit dem proximalen Ende des Außenrohrs (125) zu verbinden.
  4. Mechanisches Ösophagusverschiebesystem (1) nach Anspruch 1, wobei das Einführungselement ferner mehrere röntgendichte Markierungen (414) umfasst, die proximal zu einer Stelle positioniert sind, an der sich der Drehzapfen innerhalb des Einführungselements befinden würde, wobei sich die mehreren röntgendichten Markierungen distal von dem Ort zur Tubenspitze erstrecken.
  5. Mechanisches Ösophagusverschiebesystem (1) nach Anspruch 1, wobei die mehreren Vakuumlöcher (3) längs einer Außenfläche des Außenrohrs (125) so angeordnet sind, dass mindestens ein Teil der mehreren Vakuumlöcher mindestens einen Teil des Außenrohrs überspannt, der dazu bestimmt ist, das zweite Segment der Ösophaguspositioniervorrichtung zu bedecken, wenn die Ösophaguspositioniervorrichtung (13) vollständig in dem Einführungselement (2) aufgenommen ist.
  6. Mechanisches Ösophagusverschiebesystem (1) nach Anspruch 1, wobei das Außenrohr (125) ein Multi-Durometer-Material umfasst, so dass die Steifheit des Außenrohrs längs des Körpers des Außenrohrs variiert.
  7. Das mechanische Ösophagusverschiebesystem (1) nach Anspruch 1 umfassend ferner einen Rückkopplungsmechanismus, der anzeigt, inwieweit eine Vakuumdichtung zwischen der Anordnung und einem Ösophagus ausgebildet worden ist.
  8. Mechanisches Ösophagusverschiebesystem nach einem der vorhergehenden Ansprüche, wobei das zweite Segment (115) so bemessen ist, dass es die Ösophaguswand bei der Artikulation um etwa 4 Zentimeter verschiebt.
  9. Mechanisches Ösophagusverschiebesystem nach einem der vorhergehenden Ansprüche, wobei das zweite Segment (115) eine distale Bandlaminatanordnung (12), einen distalen Bandschutz (8) und einen distalen Drehhalter (14) umfasst, wobei die distale Bandanordnung mehrere distale Bänder (185)aufnimmt, in denen alle außer einem der Bänder einen Schlitz an einem distalen Ende der mehreren distalen Bänder aufweisen, wobei das eine Band eher ein Loch als einen Schlitz am distalen Ende aufweist, wobei der distale Bandschutz die distale Bandanordnung durch einen Stift hält, der durch die mehreren distalen Bänder hindurchgeht, und wobei der distale Schutz eine abgerundete Spitze aufweist.
  10. Mechanisches Ösophagusverschiebesystem nach Anspruch 9, wobei das erste Segment einen proximalen Schwenkhalter (15), ein Gelenkantriebskabel (18) und eine proximale Bandlaminatanordnung (19) umfasst, die mehrere proximale Bänder (210) umfasst, wobei der proximale Schwenkhalter die proximale Laminatbandanordnung aufnimmt, wobei der proximale Schwenkhalter den distalen Schwenkhalter daran hindert, um mehr als 45 Grad zu jeder Seite zu schwenken, um das Risiko einer Beschädigung des Ösophagus aufgrund einer übermäßigen Translation zu verhindern.
  11. Mechanisches Ösophagusverschiebesystem nach Anspruch 10, wobei das zweite Segment über einen Gelenkdrehzapfen schwenkbar mit dem ersten Segment in Kontakt steht und wobei der Gelenkdrehzapfen sowohl den distalen Schwenkhalter als auch den proximalen Schwenkhalter miteinander verbindet und ihnen ein Schwenken ermöglicht.
  12. Mechanisches Ösophagusverschiebesystem nach Anspruch 11, wobei das zweite Segment über einen Gelenkdrehzapfen schwenkbar mit dem ersten Segment verbunden ist und wobei das Gelenkantriebskabel eine Eingabe von einem Benutzer durch den Griff auf den Gelenkdrehzapfen überträgt, um die Vorrichtung um etwa 45 Grad nach links oder rechts zu schwenken.
  13. Das mechanische Ösophagusverschiebesystem nach einem der vorhergehenden Ansprüche umfasst ferner einen oder mehrere Sensoren an der Rohrspitze.
  14. Das mechanische Ösophagusverschiebesystem nach einem der vorangehenden Ansprüche, wobei das Außenrohr (125) ein Multi-Durometer-Material umfasst, so dass die Steifheit des Außenrohrs längs des Körpers des Außenrohrs variiert.
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AU2018210381B2 (en) 2023-08-17
US20180200416A1 (en) 2018-07-19
JP7216651B2 (ja) 2023-02-01
IL298033A (en) 2023-01-01
EP3570772A4 (de) 2020-11-18
EP4316389A3 (de) 2024-05-29
AU2023266355A1 (en) 2023-12-07
EP4316389A2 (de) 2024-02-07
US11890406B2 (en) 2024-02-06
CA3051110A1 (en) 2018-07-26
EP3570772A1 (de) 2019-11-27
US10307520B2 (en) 2019-06-04
US20240197979A1 (en) 2024-06-20
JP2020505123A (ja) 2020-02-20
AU2018210381A1 (en) 2019-08-29
IL268174B2 (en) 2023-04-01
IL268174B (en) 2022-12-01
US20220257849A1 (en) 2022-08-18
CN110352043A (zh) 2019-10-18
US11324874B2 (en) 2022-05-10
US20190269834A1 (en) 2019-09-05
WO2018136768A1 (en) 2018-07-26
IL268174A (en) 2019-09-26

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